iCornett v. Johnson & Johnson, 414 N.J. Super 365 (App. Div. 2010), represents the first New Jersey appellate decision to address the application of federal express and implied pre-emption principles in a product liability case involving a pre-market approved (“PMA”), Class III medical device. As discussed below, Cornett reached the wrong result when the court held that plaintiffs' failure to warn claim was not expressly or impliedly pre-empted by federal law because the claim was accompanied by allegations that the defendant withheld information from the FDA. This portion of Cornett reflects an extremely narrow interpretation of the United States Supreme Court's implied pre-emption decision in Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001), and has the potential to erode the express pre-emption protections afforded to medical device manufacturers by Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
By way of background, in Riegel, the U.S. Supreme Court held that the express pre-emption clause of the 1976 Medical Device Amendments (“MDA”), 21 U.S.C. §360k(a), protected manufacturers of PMA, Class III medical devices from state claims which imposed requirements that were different from or in addition to those requirements already imposed by federal law. While this represented a tremendous victory for medical device manufacturers, the U.S. Supreme Court did not expressly pre-empt all state law claims. The Riegel court held that when authorized by state law, the MDA did not prevent plaintiffs from asserting claims that the manufacturer failed to adhere to federal requirements (“parallel claims”), because such claims did not impose requirements which were in addition to or different from those imposed by federal law.
Although Riegel is a landmark decision, it only represents half of the federal pre-emption picture. Even if a claim is not expressly pre-empted by the MDA, it may be precluded by implied pre-emption principles if assertion of the claim would conflict with federal law. In Buckman, the U.S. Supreme Court held that implied pre-emption principles precluded plaintiffs from asserting claims alleging that the defendant committed “fraud on the FDA.” Since Buckman was decided, courts throughout the country have found claims to be impliedly pre-empted where the claim was based on allegations that the manufacturer made misrepresentations to or withheld information from the FDA. For example, in McDarby v. Merck & Co., Inc., 401 N.J. Super. 10 (App. Div. 2008), the New Jersey Appellate Division held that the provision of the New Jersey Product Liability Act (“NJPLA”) that eliminates the punitive damages immunity provided to manufacturers of FDA-approved products where the manufacturer knowingly withheld information from the FDA, was impliedly pre-empted under Buckman.
The Appellate Division's decision in Cornett on plaintiffs' failure to warn claim represents a clear departure from Buckman and McDarby. In Cornett, several plaintiffs brought suit against Johnson & Johnson (“J&J”) seeking recovery for injuries allegedly caused by the company's Cypher stent product, a PMA, Class III medical device. Plaintiffs' Master Complaint asserted claims for design defect, manufacturing defect, failure to warn and breach of express warranties. Plaintiffs' Complaint was replete with allegations that J&J violated various provisions of the Food, Drug and Cosmetic Act (“FDCA”) and FDA regulations. Relying on Riegel, J&J filed a motion to dismiss plaintiffs' entire Master Complaint on the grounds that the claims were barred by express pre-emption principles. The trial court agreed, and dismissed the Master Complaint in its entirety.
The New Jersey Appellate Division affirmed the trial court's decision in part, and reversed it in part. The court acknowledged that in light of Riegel and Buckman, plaintiffs were limited in the types of claims they could assert against manufacturers of PMA, Class III medical devices:
[T]o avoid the statutory preemption of state requirements that vary from federal requirements, a state claim concerning PMA devices must be parallel to the federal requirements, meaning that the state requirements it embodies must not impose any duty on the manufacturer beyond satisfying the federal requirements. However, to avoid the implied preemption of claims outside the traditional areas of state regulation, a claim concerning PMA devices must also represent a traditional state cause of action that would impose a duty on the manufacturer even if there were no federal requirements at all to be referenced, much less violated.
In applying this standard, the Appellate Division found that plaintiffs' failure to warn claim was not pre-empted by either Riegel or Buckman. The court explained that under the NJPLA, a warning that is approved by the FDA carries a rebuttable presumption of adequacy. In Perez v. Wyeth Labs, 161 N.J. 1, 25 (1999) (decided two years prior to Buckman), the New Jersey Supreme Court held that this presumption of adequacy can be rebutted by evidence that the manufacturer deliberately concealed safety information from the FDA.
Relying on these principles, the Cornett court correctly held that plaintiffs' failure to warn claim was expressly pre-empted under Riegel if it were based solely on the theory that the defendant should have included a warning that the FDA did not require to be included in the product label. Such a claim would impose labeling requirements different from or in addition to those already imposed by the FDA. The Cornett court, however, took the analysis a step further and held that because plaintiffs were alleging that the defendant deliberately concealed post-marketing safety information from the FDA, plaintiffs had pled sufficient facts to rebut the presumption of adequate labeling under Perez to survive a motion to dismiss. The Cornett court reasoned that such a claim was not expressly pre-empted under Riegel because plaintiffs alleged that the defendant concealed safety information from the FDA in violation of FDA regulations, therefore stating a valid parallel claim. Furthermore, even though plaintiffs' failure to warn claim was premised on allegations that J&J withheld information from the FDA, the court held that this allegation did not qualify as a “fraud on the FDA” claim precluded by Buckman because plaintiffs' claim fell within an area of traditional state law, i.e. the NJPLA and Perez, which existed even in the absence of FDA regulations. In reaching this conclusion, the Cornett court severely limited the protections provided to manufacturers by Buckman, and ignored McDarby in which a different panel of the Appellate Division found that “fraud on the FDA” language in the punitive damages provision of the NJPLA was pre-empted by Buckman.
The remainder of the Cornett decision comported with the majority of post-Riegel decisions around the country. The court held that plaintiffs' design defect claim was pre-empted as a matter of law. It held that the manufacturing defect claim constituted a valid parallel claim under Riegel because it was premised on allegations that the defendant failed to adhere to device-specific manufacturing requirements imposed by the FDA. The court held that to the extent that plaintiffs were basing their express warranty claim on statements contained in the product label, package insert or other product materials that the FDA reviewed and approved, such a claim was expressly pre-empted. However, to the extent that plaintiffs based their express warranty claim on J&J's marketing or promotional materials, which were not mandated or approved by the FDA, the court held that plaintiffs' express warranty claim was not pre-empted.
What Does This Case Mean?
The Cornett court applied an overly narrow view of Buckman's implied pre-emption principles as they affect the assertion of failure to warn claims under New Jersey law. Although plaintiffs did not label their claim as a “fraud on the FDA” claim, substantively there really is no difference. Plaintiffs' failure to warn claim was premised on the theory that the defendant withheld certain information from the FDA - exactly the type of claim that is precluded by Buckman. Similarly, the Cornett decision appears to be at odds with the result reached in McDarby. Currently, the Cornett decision is the subject of a petition for certification with the New Jersey Supreme Court. We will continue to monitor and report on any new developments on this important decision.
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